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Keep an eye on U.S. beef

flounder

Well-known member
Thursday, Aug. 3, 2006

EDITORIAL
Keep an eye on U.S. beef

The government has lifted its ban on imports of U.S. beef, but suspicions about the safety of American beef still linger in Japan. This sentiment is epitomized by a statement by health minister Jiro Kawasaki. He said that if risk materials -- parts of the cow where prions, the infectious agents of bovine spongiform encephalopathy (BSE) or mad cow disease, can exist -- are found again in imported U.S. beef, all beef shipments from the United States would be halted and he would probably have to resign.

U.S. beef was first banned in December 2003 after a Canadian-born cow in Washington state tested positive for BSE. The ban was lifted in December 2005, but reinstated the following month after spinal material, a risk part, was discovered in a shipment of U.S. veal. The latest Japan-U.S. agreement includes the following conditions: cattle slaughtered for beef export to Japan must be less than 21 months old, BSE-risk parts such as brains and spinal cords must be removed and the beef must come from authorized meat-processing plants. The government says it will inspect all beef imports "for the time being."

Given the public's suspicions, it is important to give consumers accurate information on the origin of beef. At present, all beef products do not carry such information. Regulations vary in accordance to processing, such as whether the beef has been heated or frozen, and whether it is mixed with other meats or vegetables. The government should make it mandatory that all beef products indicate country of origin.

One way to gain the confidence of Japanese consumers would be to limit U.S. beef imports to cows raised only on grass and grain at authorized ranches, and to sell it attached with relevant information on the cows, including their age and origin.

The government also must do its utmost to ensure the safety of domestic beef. It must heed the government BSE panel's finding in its December 2005 report that pithing, a procedure in which the spinal cord is destroyed by inserting a needle into the vertebral canal, is carried out on 80 percent of slaughtered cattle and increases the risk of prion contamination of meat.
The Japan Times
(C) All rights reserved



:lol: :lol2: :help:



New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217

Telephone: 615-781-5380
Fax: 615-781-5391



May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).

Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.

This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.

You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez
Acting District Director
New Orleans District


http://www.fda.gov/foi/warning_letters/g5883d.htm


MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

###





http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html



Audit Report

Animal and Plant Health Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II

and

Food Safety and Inspection Service

Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III



Report No. 50601-10-KC January 2006



Executive Summary

Animal and Plant Health Inspection Service - Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and Food Safety and Inspection Service - Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III

Results in Brief This report evaluates elements of the interlocking safeguards in place to protect United States (U.S.) beef from Bovine Spongiform Encephalopathy, widely known as BSE or "mad cow disease." Since 1990, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), has led a multi-agency effort to monitor and prevent BSE from entering the food supply. After discovering a BSE-positive cow in December 2003, APHIS expanded its BSE surveillance program. To further protect the food supply, USDA banned materials identified as being at risk of carrying BSE (specified risk materials (SRM)), such as central nervous system tissue. As part of this effort, USDA’s Food Safety and Inspection Service (FSIS) required beef slaughter and processing facilities to incorporate controls for handling such materials into their operational plans. Onsite FSIS inspectors also inspect cattle for clinical signs in order to prevent diseased animals from being slaughtered for human consumption. To evaluate the effectiveness of the safeguards, we assessed APHIS’ implementation of the expanded surveillance program, as well as FSIS’ controls to prevent banned SRMs from entering the food supply.

In June 2004, APHIS implemented its expanded surveillance program; participation by industry in this surveillance program is voluntary. As of May 2005, over 350,000 animals were sampled and tested for BSE. To date, two animals tested positive for BSE; one tested positive after implementation of the expanded surveillance program.

USDA made significant efforts to implement the expanded BSE surveillance program. Much needed to be done in a short period of time to establish the necessary processes, controls, infrastructure, and networks to assist in this effort. In addition, extensive outreach and coordination was undertaken with other Federal, State, and local entities, private industry, and laboratory and veterinary networks. This report provides an assessment as to the progress USDA made in expanding its surveillance effort and the effectiveness of its controls and processes. This report also discusses the limitations of its program and data in assessing the prevalence of BSE in the U.S. herd.

Surveillance Goals and Objectives

In March 2004, USDA published its plan to expand the BSE surveillance program. The plan’s goal was to collect samples from as many adult1 cattle from the high-risk population as possible in 12-18 months while ensuring that there was statistically appropriate geographical representation of the adult cattle population in the United States. Overall, USDA designed the program to define whether BSE was actually present in the U.S. cattle population and if so, to what level.

When USDA published its plan, Office of Inspector General (OIG) was examining the pre-expansion program. In anticipation of the coming changes, we reviewed the plan in order to determine if its design would allow the Department to reach statistically valid conclusions about the presence and level of BSE. Since the implementation plan had not been finalized, we provided recommendations for USDA to consider as they moved forward with implementing an expanded surveillance program. In August 2004, we released our report, Animal and Plant Health Inspection Service and Food Safety and Inspection Service, Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase I (Report No. 50601-9-KC), which discussed our observations of the challenges USDA faced in meeting its stated goals and made 19 recommendations for USDA to consider as it moved forward with implementation. Our prior report primarily focused on (1) the potential for unwarranted statistical conclusions to be drawn from the data USDA planned to collect, and (2) the challenges in identifying and testing high-risk cattle. In response to our report, APHIS agreed to disclose the limitations of the data and the assumptions made and its impact on any statistical representations regarding the prevalence of BSE in order to obviate misinterpretation.

We reviewed the specific corrective actions APHIS and FSIS agreed to take in response to prior audit recommendations during this audit. In this report, we discuss the specific areas where corrective actions were not fully effective in addressing our concerns in the following areas: obtaining representative samples, identifying and obtaining samples from the high-risk surveillance streams, and completeness and accuracy of program data.

APHIS has provided OIG unpublished drafts of its preliminary analysis, which included various statistical approaches to determining the prevalence of BSE. In general, each approach mitigates some, but not all of the limitations associated with its data and underlying assumptions in the design and implementation of its surveillance program. Some of the approaches also

1 FSIS considers bulls and cows to be mature cattle with cows ordinarily having given birth to one or more calves. FSIS defines SRMs to be present in cattle 30 months of age or older, while APHIS defines its target population for BSE sampling to be over 30 months of age. Dentition is used to estimate the age ranges of cattle. Dentition is the development of teeth and their arrangement in the mouth.

USDA/OIG-A/50601-10-KC/ Page iii

introduce new challenges because any conclusions are extremely sensitive to the accuracy of the underlying data. The accuracy of the underlying data is also critical to the development of a future maintenance surveillance program. We cannot fully assess any of the approaches being considered by APHIS since it has not finalized its analysis. In Finding 1, however, we do offer several observations for APHIS to consider as it develops its conclusions about the prevalence of BSE in the U.S. cattle population.

Inherent Limitations in Identifying and Testing High-Risk Cattle

APHIS obtained significantly more samples for testing than they originally anticipated would be needed to achieve its stated level of confidence in estimating the prevalence of BSE in the U.S. herd. Because of the voluntary nature of its program, however, we could not determine how successful APHIS was in obtaining a representative proportion of high-risk cattle for testing. Our prior report recognized the significant challenges for APHIS to obtain samples from the high-risk population because of the inherent problems with obtaining voluntary compliance and transporting carcasses for testing. APHIS took steps to obtain facilitated pathways, by entering into over 100 agreements, to collect and test brain samples for BSE. However, using USDA published data that estimates the distribution of the cattle population, as well as those that died or became nonambulatory, we could not determine whether APHIS achieved either geographical representation or representation of the desired surveillance stream (clinical suspects, fallen stock, casualty slaughter fallen stock, and routine slaughter). Findings 1 and 2 present the conditions noted that impact this evaluation.

USDA Testing Protocols and Quality Assurance Procedures

In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE.

Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that

USDA/OIG-A/50601-10-KC/ Page iv

conducting additional tests would undermine confidence in USDA’s testing protocols.

OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results.

To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test.

We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4.

Controls (Firewalls) to Prevent BSE in the Food Supply

USDA instituted proactive procedures to prevent tissues and products that could possibly contain the infective agent for BSE from entering the food supply. FSIS performs inspections on cattle before slaughter (ante mortem) to observe clinical signs that may indicate a central nervous system disorder or other signs that may be associated with BSE. Such animals are condemned and prohibited from slaughter for human consumption. FSIS also identified high-risk beef tissue and products as SRMs, and banned them from the food supply. FSIS inspects slaughter processes to verify that slaughterhouses have incorporated controls for handling SRMs into their operational plans; adequate procedures must be in place for removing, segregating, and disposing of SRMs.

OIG reviewed the SRM plans of several establishments, observed FSIS inspection procedures, and evaluated the effectiveness of controls during the slaughter process. We did not identify SRMs entering the food supply. However, due to the lack of adequate records, we could not determine whether SRM procedures were followed and/or were adequate in 9 of

2 For purposes of this report, the term renderers also includes pet food manufacturers and plants that handle dead, dying, disabled, or diseased livestock.

3 9 CFR 320.5, states that every person that engages in business in or for commerce, as a meat broker, renderer, or animal food manufacturer … shall register with the Administrator [of FSIS].

12 establishments visited during the audit. There is no requirement in the United States for the age of animals to be recorded, therefore, APHIS and FSIS rely on meat establishments to determine the age of cattle slaughtered using documentation or dentition. SRM restrictions apply predominantly to cattle 30 months of age or older. FSIS periodically checks the accuracy of age determinations through dentition; however, we could not determine how often these checks are made. We found that improvements can be made in the following areas.


• FSIS approved an alternate ante mortem inspection procedure that limited the number of cattle subject to inspection. FSIS discontinued this procedure during the audit.


• FSIS does not have an information system capable of readily identifying the scope of, and trends in, noncompliance violations relating to SRMs.


• Most of the establishments reviewed did not have adequate SRM plans, and FSIS did not always identify these deficiencies.

• Several of the establishments did not comply with their SRM plans and/or maintain records to support that they follow their plans.

FSIS has addressed the specific cases of noncompliance identified during the audit. Findings 5 through 9 discuss our assessment of the effectiveness of USDA’s firewalls.

Other Program Administration Issues

FSIS and APHIS did not maintain current and comprehensive listings of renderers2 and related businesses. These entities are required to register with FSIS as a condition of engaging in business.3 As a result, should serious animal diseases be detected in the United States, USDA’s ability to quickly determine and trace the source of infections to prevent the spread of the disease could be impaired. Also, APHIS could not use the registrations to identify potential sources to mitigate geographical gaps in BSE testing. We discuss the details of this issue in Finding 11.

We also determined that an APHIS area office paid costs for sampling and carcass transportation, storage, and disposal that exceeded national cost recovery guidelines and/or that were ineligible for reimbursement. The area office entered into 10 reimbursable agreements before national office cost recovery guidelines had been issued but did not adjust the agreements afterwards although instructed to do so by the national office. Instead, the area office included the questionable costs in amounts proposed (by

USDA/OIG-A/50601-10-KC/ Page vi

third parties) in other allowable cost categories. The area office official stated he changed supporting records because he believed he should honor the prior negotiated costs. As a result, at least $1.2 million of about $11.2 million paid were unsupported program costs. Finding 12 more fully examines the unsupported costs and why they went undiscovered.

The expanded stage of USDA’s BSE surveillance program is nearing its end. Accordingly, it is vital that the conditions summarized above be considered as USDA uses the data gathered to design an effective BSE surveillance maintenance program and to report its assessment of the prevalence of BSE in the U.S. herd. In particular, APHIS must develop testing protocols which are grounded in science and flexible enough to adapt to changing circumstances. For its part, FSIS must ensure that it effectively monitors SRM handling practices to ensure they comply with Federal regulations. Implemented, these management controls will help USDA continue to effectively safeguard the U.S. beef supply for consumers.





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full text 130 pages ;



http://www.usda.gov/oig/webdocs/50601-10-KC.pdf



TSS
 

PORKER

Well-known member
FROM a COUNTRY that KNOWS BSE
Given the public's suspicions, it is important to give consumers accurate information on the origin of beef. At present, all beef products do not carry such information. Regulations vary in accordance to processing, such as whether the beef has been heated or frozen, and whether it is mixed with other meats or vegetables. The government should make it mandatory that all beef products indicate country of origin.

One way to gain the confidence of Japanese consumers would be to limit U.S. beef imports to cows raised only on grass and grain at authorized ranches, and to sell it attached with relevant information on the cows, including their age and origin.

The government also must do its utmost to ensure the safety of domestic beef. It must heed the government BSE panel's finding in its December 2005 report that pithing, a procedure in which the spinal cord is destroyed by inserting a needle into the vertebral canal, is carried out on 80 percent of slaughtered cattle and increases the risk of prion contamination of meat.
The Japan Times
(C) All rights reserved
 
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